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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIOTRON PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
Generic NameASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
ApplicantDiasorin
1951 Northwestern Ave.
Stillwater, MN 55082
PMA NumberP970055
Supplement NumberS001
Date Received11/15/2002
Decision Date01/09/2003
Product Code MYM 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING A QUALITY ASSURANCE INSPECTION STEP.
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